A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
NCT ID: NCT07140913
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
424 participants
INTERVENTIONAL
2025-10-08
2027-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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KarXT + Lithium, Valproate, or Lamotrigine
Xanomeline/Trospium Chloride
Specified dose on specified days
Lithium
Specified dose on specified days
Valproate
Specified dose on specified days
Lamotrigine
Specified dose on specified days
Placebo + Lithium, Valproate, or Lamotrigine
Lithium
Specified dose on specified days
Valproate
Specified dose on specified days
Lamotrigine
Specified dose on specified days
Placebo
Specified dose on specified days
Interventions
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Xanomeline/Trospium Chloride
Specified dose on specified days
Lithium
Specified dose on specified days
Valproate
Specified dose on specified days
Lamotrigine
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Individual is experiencing an acute exacerbation or relapse of manic episode, with or without mixed features (≤ 3 weeks).
* The individual requires hospitalization for the acute exacerbation or relapse of mania.
* Body mass index ≥ 18 and ≤ 40 kg/m2
* Currently experiencing an acute episode of mania or mania with mixed features with a therapeutic dose of lithium, valproate, or lamotrigine. The dose of the mood stabilizer must have remained stable for at least two weeks prior to screening. Additionally, participants on valproate must have been receiving treatment with valproate for a minimum of seven months.
* YMRS Total Score of ≥ 18 at Screening and at Baseline, and \< 20% reduction in YMRS from screening to baseline.
* Clinical Global Impression Severity scale (CGI-BP) ≥ 4
Exclusion Criteria
* Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening (confirmed using MINI version 7.0.2 Standard at screening), or current use as determined by urine toxicology screen or alcohol test.
* Risk for suicidal behavior at screening as determined by the investigator's clinical assessment and the C-SSRS with an answer "Yes" to item 4 or 5 within 6 months before screening or between screening and baseline, or suicide attempt within 12 months before screening, or between screening and baseline
* History of irritable bowel syndrome (with or without constipation) or any serious constipation requiring treatment within the last 6 months.
* History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.
* Participants with HIV, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or the LFT results.
* Elevations in hepatic transaminases at screening ≥ 2 × ULN for ALT and AST and/or bilirubin \> 1.5× ULN, unless in the context of Gilbert's syndrome.
* All grades of hepatic impairment (mild \[Child-Pugh Class A\], moderate \[Child-Pugh Class B\], and severe \[Child-Pugh Class C\]).
18 Years
65 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Pillar Clinical Research - Bentonville
Bentonville, Arkansas, United States
Pillar Clinical Research- Little Rock
Little Rock, Arkansas, United States
Clinical Innovations, Inc. dba CITrials
Bellflower, California, United States
Inland Psychiatric Medical Group - Chino
Chino, California, United States
Local Institution - 0014
Culver City, California, United States
Local Institution - 0151
La Habra, California, United States
Local Institution - 0037
Montclair, California, United States
Local Institution - 0148
Orange, California, United States
Clinical Innovations, Inc. dba CITrials
Riverside, California, United States
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, United States
South Florida Research Phase I-IV
Miami Springs, Florida, United States
Health Synergy Clinical Research
Stuart, Florida, United States
CenExel iResearch, LLC
Savannah, Georgia, United States
Pillar Clinical Research -Chicago
Chicago, Illinois, United States
Arch Clinical Trials
St Louis, Missouri, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Local Institution - 0026
Austin, Texas, United States
Local Institution - 0160
Houston, Texas, United States
Local Institution - 0156
Mansfield, Texas, United States
Pillar Clinical Research - Richardson
Richardson, Texas, United States
Local Institution - 0011
ABB, Buenos Aires F.D., Argentina
Local Institution - 0010
Córdoba, , Argentina
Local Institution - 0012
Córdoba, , Argentina
Local Institution - 0008
Córdoba, , Argentina
Local Institution - 0009
Mendoza, , Argentina
Local Institution - 0114
Santiago del Estero, , Argentina
Local Institution - 0184
Kazanlak, Stara Zagora, Bulgaria
Local Institution - 0124
Novi Iskar, , Bulgaria
Local Institution - 0084
Pleven, , Bulgaria
Local Institution - 0125
Plovdiv, , Bulgaria
Local Institution - 0181
Sliven, , Bulgaria
Local Institution - 0086
Targovishte, , Bulgaria
Local Institution - 0185
Beijing, , China
Local Institution - 0088
Hillerød, Capital Region, Denmark
Local Institution - 0054
Aalborg, North Denmark, Denmark
Local Institution - 0091
Glostrup Municipality, , Denmark
Local Institution - 0126
Nice, Alpes-Maritimes, France
Local Institution - 0085
Clermont-Ferrand, Puy-de-Dôme, France
Local Institution - 0087
Marseille, , France
Local Institution - 0129
Montpellier, , France
Local Institution - 0089
Paris, , France
Local Institution - 0121
Mangalore, Karnataka, India
Local Institution - 0123
Madurai, Tamil Nadu, India
Local Institution - 0118
Kolkata, West Bengal, India
Local Institution - 0116
Kolkata, , India
Local Institution - 0052
Hod HaSharon, Central District, Israel
Local Institution - 0051
Ness Ziona, Central District, Israel
Local Institution - 0050
Ramat Gan, Central District, Israel
Local Institution - 0053
Ashkelon, Southern District, Israel
Local Institution - 0083
Jerusalem, , Israel
Local Institution - 0090
Tirat Carmel, , Israel
Local Institution - 0003
Milan, Lombardy, Italy
Local Institution - 0005
Pisa, Tuscany, Italy
Local Institution - 0001
Siena, Tuscany, Italy
Local Institution - 0004
Ancona, , Italy
Local Institution - 0002
Genova, , Italy
Local Institution - 0173
Toyoake, Aichi-ken, Japan
Local Institution - 0172
Iizuka, Fukuoka, Japan
Local Institution - 0141
Kitakyushu-shi, Fukuoka, Japan
Local Institution - 0108
Sapporo, Hokkaido, Japan
Local Institution - 0107
Yokohama, Kanagawa, Japan
Local Institution - 0142
Kochi, Kochi, Japan
Local Institution - 0175
Karatsu, Saga-ken, Japan
Local Institution - 0180
Bunkyo-ku, Tokyo, Japan
Local Institution - 0139
Bunkyo-ku, Tokyo, Japan
Local Institution - 0176
tabashi City, Tokyo, Japan
Local Institution - 0174
Fukuoka, , Japan
Local Institution - 0103
Rybnik, Silesian Voivodeship, Poland
Local Institution - 0082
Tuszyn, Łódź Voivodeship, Poland
Local Institution - 0092
Bucharest, București, Romania
Local Institution - 0093
Bucharest, București, Romania
Local Institution - 0094
Bucharest, București, Romania
Local Institution - 0098
Bucharest, București, Romania
Local Institution - 0102
Bucharest, , Romania
Local Institution - 0096
Bucharest, , Romania
Local Institution - 0099
Bucharest, , Romania
Local Institution - 0097
Iași, , Romania
Local Institution - 0095
Sanpetru /Brasov, , Romania
Local Institution - 0101
Sibiu, , Romania
Local Institution - 0167
Smila, Cherkasy Oblast, Ukraine
Local Institution - 0178
Skarzhyntsi, Khmelnytskyi Oblast, Ukraine
Local Institution - 0169
Hlevakha, Kyiv Oblast, Ukraine
Local Institution - 0162
Kyiv, Kyivska Oblast, Ukraine
Local Institution - 0164
Lviv, Lviv Oblast, Ukraine
Local Institution - 0177
Poltava, Poltava Oblast, Ukraine
Local Institution - 0168
Vinnytsia, Vinnytsia Oblast, Ukraine
Local Institution - 0165
Dnipropetrovsk, , Ukraine
Local Institution - 0163
Kropyvnytskyi, , Ukraine
Local Institution - 0170
Odesa, , Ukraine
Local Institution - 0171
Odesa, , Ukraine
Local Institution - 0166
Ternopil, , Ukraine
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
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Fayz Hudefi, Site 0029
Role: primary
Leslie Smith, Site 0018
Role: primary
Gerald Maguire, Site 0110
Role: primary
Nandita Puchakayala, Site 0049
Role: primary
Site 0014
Role: primary
Site 0151
Role: primary
Site 0037
Role: primary
Site 0148
Role: primary
Evagelos Coskinas, Site 0106
Role: primary
Beth Safirstein, Site 0015
Role: primary
Silvia Silva Duluc, Site 0021
Role: primary
Mohammad Nisar, Site 0016
Role: primary
Yael Elfassy, Site 0136
Role: primary
Roueen Rafeyan, Site 0017
Role: primary
Junaid Syed, Site 0023
Role: primary
Peter Weiden, Site 0032
Role: primary
Site 0026
Role: primary
Site 0160
Role: primary
Site 0156
Role: primary
Scott Bartley, Site 0033
Role: primary
Site 0011
Role: primary
Site 0010
Role: primary
Site 0012
Role: primary
Site 0008
Role: primary
Site 0009
Role: primary
Site 0114
Role: primary
Site 0184
Role: primary
Site 0124
Role: primary
Site 0084
Role: primary
Site 0125
Role: primary
Site 0181
Role: primary
Site 0086
Role: primary
Site 0185
Role: primary
Site 0088
Role: primary
Site 0054
Role: primary
Site 0091
Role: primary
Site 0126
Role: primary
Site 0085
Role: primary
Site 0129
Role: primary
Site 0121
Role: primary
Site 0123
Role: primary
Site 0118
Role: primary
Site 0116
Role: primary
Site 0052
Role: primary
Site 0051
Role: primary
Site 0050
Role: primary
Site 0053
Role: primary
Site 0083
Role: primary
Site 0090
Role: primary
Site 0003
Role: primary
Site 0005
Role: primary
Site 0001
Role: primary
Site 0004
Role: primary
Site 0002
Role: primary
Site 0173
Role: primary
Site 0172
Role: primary
Site 0108
Role: primary
Site 0107
Role: primary
Site 0142
Role: primary
Site 0175
Role: primary
Site 0180
Role: primary
Site 0139
Role: primary
Site 0176
Role: primary
Site 0174
Role: primary
Site 0103
Role: primary
Site 0082
Role: primary
Site 0092
Role: primary
Site 0093
Role: primary
Site 0094
Role: primary
Site 0098
Role: primary
Site 0102
Role: primary
Site 0096
Role: primary
Site 0099
Role: primary
Site 0097
Role: primary
Site 0095
Role: primary
Site 0101
Role: primary
Site 0167
Role: primary
Site 0178
Role: primary
Site 0169
Role: primary
Site 0162
Role: primary
Site 0164
Role: primary
Site 0177
Role: primary
Site 0168
Role: primary
Site 0165
Role: primary
Site 0163
Role: primary
Site 0170
Role: primary
Site 0171
Role: primary
Site 0166
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2025-521845-26
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1321-1513
Identifier Type: OTHER
Identifier Source: secondary_id
CN012-0046
Identifier Type: -
Identifier Source: org_study_id
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